Scientific Research Integrity

Academic institutions and medical research centers that receive federal funds for research have tremendous exposure in the event of a misdeed or deliberate act by an individual person or research team. The institution has exposure if it disregards processes or fails to oversee research.

With hundreds of physicians, scientists and researchers, multiple and overlapping departments and supervisors, and numerous grants and funding sources, ensuring protocols and standards can be daunting. It takes only one person to ignore procedures or, worse, deliberately alter or fabricate data, to damage an institution’s reputation and create financial and legal liability.

As a recipient of federal funds for scientific research, institutions needs to ask (and be able to answer) themselves the following questions with confidence.

• Are you confident in your research integrity compliance program and protocols?
• Are you aware of when research misconduct leads to False Claims Act exposure?
• In the event of misconduct can you execute an internal investigation?
• And in response to an allegation of fraud, are you prepared for a full government inquiry?
• How – and when – do you decide to make a disclosure to the federal government about your possible False Claims Act liability?
• How – and when – do you use the information and evidence that is emerging from an internal research misconduct investigation to decide that False Claims Act liability exists and needs to be addressed?
• How do you head off liability before an FCA claim is filed?

If any of the questions raise concerns, then the institution is at risk. If not handled properly, the situation can escalate quickly. Exposure exists whether a deliberate act or the result of poor
procedural compliance.

Foley can help. Knowing when and how to disclose the potential misconduct can mean the difference between heavy penalties and securing a favorable outcome. Foley is expert at advising research institutions with lawyers that know the regulatory landscape and with real experience advising on compliance issues and how to disclose.